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Autism Spectrum Disorder (ASD)NCT07421830

An Empowering Parent Training Intervention to Increase Physical Activity in Preschool Aged Children With Autism

A study testing Wellness Enhancing Physical Activity for Young Children: Parent Version (WE PLAY for Parents) in people with Autism Spectrum Disorder (ASD), run by Northeastern University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to learn if WE PLAY for Parents can improve caregivers' knowledge, attitudes, confidence, and skills promoting physical activity with their young child with autism. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Autism Spectrum Disorder (ASD)
What is being tested?
Wellness Enhancing Physical Activity for Young Children: Parent Version (WE PLAY for Parents)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
1 siteUnited States
Study dates
20 Feb 2026to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Parents or caregivers (who are at least 18 years of age) of children with a diagnosis of autism.
  • The autism diagnosis for the child can be from a school or medical setting.
  • The parent or caregiver's child with autism must be between 2 years 11 months and 5 years, 11 months of age.
  • Parent or caregivers must be able to read and write in English.

Who cannot join

  • Parents or caregivers who do not have a child with autism.
  • Adults who do not have children.
  • Parents or caregivers who cannot read and write in English.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Haley V Medeiros, M.S./CAGs contact

5086540724

medeiros.ha@northeastern.edu

United States1 site, 1 recruiting
  • Northeastern University

    Boston, Massachusetts, 02115

    Haley V Medeiros, MS/CAGs, 617-373-5257, medeiros.ha@northeastern.edu

    Jessica Hoffman, PhD, NCSP, j.hoffman@northeastern.edu

    Recruiting

Other trials in United States

About this study

Official title: An Empowering Parent Training Intervention to Increase Physical Activity in Preschool Aged Children With Autism: A Randomized Control Trial

The goal of this clinical trial is to learn if WE PLAY for Parents can improve caregivers' knowledge, attitudes, confidence, and skills promoting physical activity with their young child with autism. The main questions it aims to answer are: (1) Do participants who complete WE PLAY for Parents improve their knowledge, behavior intentions, perceived behavior control, self-efficacy, and parenting practices related to physical activity promotion with their child (Primary Hypotheses); and (2) Do participants view WE PLAY for Parents as acceptable, understandable, and feasible [secondary hypothesis)?

Researchers will compare the WE PLAY for Parents group [experimental arm] to a Waitlist Control group to see if there are differences in the variables listed in the primary hypothesis.

Read more

Participants will: (1) Complete a set of questionnaires at three timepoints: pre-training, post-training, and 3-month follow-up that each take between 10-15 minutes; (2) be randomly assigned to take the training over the next two weeks or be offered the training after 3 months.

The online training takes about 90 minutes. It includes watching informational videos, viewing video clips of adults helping children be active, reading handouts on behavior management tips and social stories, participating in an anonymous discussion board with other parents, and completing a self-assessment.

Read the detailed description

After completing a study interest form to determine eligibility and providing informed consent, participants will be randomized to the WE PLAY for Parents or a Waitlist Control group. At week 0, all participants will complete the pre-test survey and WE PLAY for Parents group participants will receive access to the WE PLAY for Parents intervention. At week 2, participants in both groups will complete a post-training survey. At week 14, participants in both groups will complete a three-month follow-up survey. At week 14, after completing the third survey, participants in the Waitlist Control group will receive access to WE PLAY for Parents.

Being tested
Wellness Enhancing Physical Activity for Young Children: Parent Version (WE PLAY for Parents)
Keywords
parents, autism, physical activity, preschoolers, health promotion, active play, caregivers
Medical subject headings
Autism Spectrum Disorder, Autistic Disorder, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Wellness Enhancing Physical Activity for Young Children: Parent Version (WE PLAY for Parents)Behavioural

    WE PLAY for Parents is an online intervention that includes an asynchronous online training with written material about physical activity promotion. Users view video clips of adults promoting active play with young children, review handouts with behavior management tips and social stories, participate in an anonymized discussion board with other parent participants, and complete a self-assessment. Intervention completion is takes between 1.5 to 2 hours.

Study groups in NCT07421830
Study groupRoleWhat they receive
WE PLAY for Parents GroupExperimentalParticipants in the WE PLAY for Parents Group will be asked to complete the intervention in the first two weeks of the study period.
Receives: Behavioral: Wellness Enhancing Physical Activity for Young Children: Parent Version (WE PLAY for Parents)
Control GroupNo interventionParticipants in the Waitlist Control group will be given access to the WE PLAY for Parents training after their study data collection is complete. This group will not receive any intervention during the data collection period.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Pre-Training in Parental Confidence in Promoting Physical Activity for their Children on the Preschool Parent Confidence Questionnaire (PPCQ) at Week 2

    The PPCQ is a 17-item, self-report instrument measuring parental confidence in promoting physical activity for their children (Coleman, 2010). The 17 items are rated 0 (not confident)-10 (totally confident), yielding a total score (0-170) with higher scores indicating higher parental self-efficacy. The PPCQ demonstrates strong reliability (α = 0.92-0.94).

    Measured: Pre-training (Week 0), Post-training (Week 2)

  2. Change from Pre-Training in Parental Physical Activity Knowledge at Week 2

    The physical activity knowledge test measures parental knowledge of physical activity promotion among young children with autism. The measure contains 10 multiple-choice items that were developed based on content from the WE PLAY for Parents online intervention. Scores range from 0-10 with higher scores indicating stronger knowledge.

    Measured: Pre-training (Week 0), Post-training (Week 2)

  3. Change from Pre-Training in Parental Behavioral Intention and Perceived Behavioral Control on the Adapted Early Childhood Educator Movement Behavioral Intention and Perceived Control Questionnaire (ECE-MBIPC) at Week 2

    An adapted version of the validated ECE-MBIPC assesses behavior intentions and perceived behavior control over five physical activity-related behaviors. The 10 items are rated using a 7-point, Likert-type scale, and generate composite scores for behavioral intention (5 items) and perceived control (5 items), with higher scores indicating greater likelihood of engagement. Composite scores range from 0-35 for behavioral intention and perceived control. The ECE-MBIPC questionnaire shows high internal consistency (Cronbach's alpha > 0.85 across subscales) (Bruijns et al., 2023).

    Measured: Pre-training (Week 0), Post-training (Week 2)

  4. Change from Pre-Training in Parental Physical Activity Promotion Practices on the Preschooler Physical Activity Parenting Practices (PPAPP) at Week 14

    The Engagement subscale of the PPAPP measures parental encouragement of physical activity. This subscale includes 15 items that are rated using a 5-point scale. Scores range from 0-75 and higher scores indicate more frequent PA-promoting practices. Cronbach's α values= 0.87-0.92 (O'Connor et al., 2014).

    Measured: Pre-training (week 0), 3-month Follow-Up (week 14).

Secondary outcomes (1)
  1. Describe Acceptability, Understanding, and Feasibility of the WE PLAY for Parents Intervention with the Usage Rating Profile-Intervention Revised (URP-IR) at Post-Training

    The URP-IR assesses intervention acceptability (7 items), understanding (3 items), and feasibility (6 items). Items are rated using a 6-point scale with higher scores reflecting greater likelihood of intervention adoption and use (α = 0.72-0.95) (Briesch et al., 2013).

    Measured: Post-training (Week 2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2026
  2. Study start20 Feb 2026
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a waitlist control RCT design. The waitlist group will receive access to the intervention (WE PLAY for Parents) at the end of their study participation (after the final data point is collected at the 3-month follow-up survey).
Masking
None (open label)
Enrolment
114 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07421830
Sponsor's protocol ID
IRB#25-12-22
Other IDs
26-C-01055
Status last verified
Apr 2026
First submitted
5 Feb 2026
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Only fully-anonymized data will be used for future research or shared with other researchers for their own studies.

Publications

  • Enders, C. K. (2010). Applied missing data analysis. Guilford Press.

  • Ajzen, I. (1991). The theory of planned behavior. Organizational Behavior and Human Decision Processes, 50(2), 179-211. https://doi.org/10.1016/0749-5978(91)90020-T

  • Agard B, Zeng N, McCloskey ML, Johnson SL, Bellows LL. Moving Together: Understanding Parent Perceptions Related to Physical Activity and Motor Skill Development in Preschool Children. Int J Environ Res Public Health. 2021 Aug 31;18(17):9196. doi: 10.3390/ijerph18179196.

    PubMed 34501785
  • Barry A, Ku B, Swarup G, Christensen LA, Columna L. Psychological factors of parental physical activity support among parents of children with disabilities: a meta-analysis. Disabil Rehabil. 2025 May;47(10):2503-2511. doi: 10.1080/09638288.2024.2399222. Epub 2024 Sep 11.

    PubMed 39259233
  • Briesch AM, Chafouleas SM, Neugebauer SR, Riley-Tillman TC. Assessing influences on intervention implementation: revision of the usage rating profile-intervention. J Sch Psychol. 2013 Feb;51(1):81-96. doi: 10.1016/j.jsp.2012.08.006. Epub 2012 Sep 20.

    PubMed 23375174
  • Bruijns, B. A., Johnson, A. M., Burke, S. M., & Tucker, P. (2023). Validation of a physical activity, sedentary behavior, and outdoor play behavioral intention and perceived behavioral control tool for early childhood educators. Early Childhood Education Journal, 51(3), 559-567. https://doi.org/10.1007/s10643-022-01314-5

  • Carson V, Lee EY, Hewitt L, Jennings C, Hunter S, Kuzik N, Stearns JA, Unrau SP, Poitras VJ, Gray C, Adamo KB, Janssen I, Okely AD, Spence JC, Timmons BW, Sampson M, Tremblay MS. Systematic review of the relationships between physical activity and health indicators in the early years (0-4 years). BMC Public Health. 2017 Nov 20;17(Suppl 5):854. doi: 10.1186/s12889-017-4860-0.

    PubMed 29219090
  • Coleman, M. B. (2010). Development and validation of the Preschool Parent Confidence Questionnaire (PPCQ): A parental self-efficacy instrument (Unpublished master's thesis). Northern Illinois University, IL.

  • Columna L, Meera B, Prieto LA, Haegele JA. The perceived influence of a physical activity intervention on the intentions of parents of autistic children towards physical activities. Disabil Health J. 2024 Oct;17(4):101637. doi: 10.1016/j.dhjo.2024.101637. Epub 2024 Apr 30.

    PubMed 38724331
  • Finch M, Jones J, Yoong S, Wiggers J, Wolfenden L. Effectiveness of centre-based childcare interventions in increasing child physical activity: a systematic review and meta-analysis for policymakers and practitioners. Obes Rev. 2016 May;17(5):412-28. doi: 10.1111/obr.12392. Epub 2016 Mar 23.

    PubMed 27005942
  • Goldstein NE, Kemp KA, Leff SS, Lochman JE. Guidelines for Adapting Manualized Interventions for New Target Populations: A Step-Wise Approach Using Anger Management as a Model. Clin Psychol (New York). 2012 Dec 1;19(4):385-401. doi: 10.1111/cpsp.12011.

    PubMed 25110403
  • Ha AS, He Q, Lubans DR, Chan CH, Ng JYY. Parent-focused online intervention to promote parents' physical literacy and support children's physical activity: results from a quasi-experimental trial. BMC Public Health. 2022 Jul 12;22(1):1330. doi: 10.1186/s12889-022-13739-z.

    PubMed 35820873
  • He, Q., Ha, A. S. C., Ng, J. Y. Y., Cairney, J., & Bedard, C. (2022). Associations between parent perceived social cognitive factors and child objectively measured physical activity behaviors among preschool-aged children. Psychology of Sport and Exercise, 61, 102200. https://doi.org/10.1016/j.psychsport.2022.102200

  • Hnatiuk JA, Brown HE, Downing KL, Hinkley T, Salmon J, Hesketh KD. Interventions to increase physical activity in children 0-5 years old: a systematic review, meta-analysis and realist synthesis. Obes Rev. 2019 Jan;20(1):75-87. doi: 10.1111/obr.12763. Epub 2018 Sep 26.

    PubMed 30257277
  • Hyman SL, Levy SE, Myers SM; COUNCIL ON CHILDREN WITH DISABILITIES, SECTION ON DEVELOPMENTAL AND BEHAVIORAL PEDIATRICS. Identification, Evaluation, and Management of Children With Autism Spectrum Disorder. Pediatrics. 2020 Jan;145(1):e20193447. doi: 10.1542/peds.2019-3447. Epub 2019 Dec 16.

    PubMed 31843864

Questions about this trial

What is this clinical trial studying?

A study testing Wellness Enhancing Physical Activity for Young Children: Parent Version (WE PLAY for Parents) in people with Autism Spectrum Disorder (ASD), run by Northeastern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Haley V Medeiros, M.S./CAGs (5086540724, medeiros.ha@northeastern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Pre-Training in Parental Confidence in Promoting Physical Activity for their Children on the Preschool Parent Confidence Questionnaire (PPCQ) at Week 2 (time frame: Pre-training (Week 0), Post-training (Week 2)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07421830, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.

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